Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

Launched by YUHAN CORPORATION · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two medications, YHP2406 and YHR2501, to see if they are similar enough in how they work in the body. The study will involve healthy volunteers who will receive a single dose of each medication at different times. The main goal is to determine if these two drugs are bioequivalent, meaning they should have the same effects and safety profiles.

To participate, individuals must be between 18 and 30 years old and have a body mass index (BMI) between 18 and 30, which indicates a healthy weight range. It's important that participants do not have any significant health issues or chronic diseases. Women who are pregnant, think they might be pregnant, or are breastfeeding cannot take part in the study. Participants can expect to receive one dose of each medication during the trial, and they will be monitored closely for safety. This study is still in the planning stages, so recruitment has not yet begun.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BMI 18-30 kg/m2
• • Those without clinically significant congenital or chronic diseases
• Exclusion Criteria:
• • Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
• • Others who are judged ineligible to participate in the trial by the principal investigator.
• • Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.